GUEST COLUMNISTS

• Setting The Tone For A Fill/Finish Engagement Program

  The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.

• FDA's Guidance On Cell And Gene CMC Codifies Flexibility

  The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.

• Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?

  Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.

• Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality

  Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.

• Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

  Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

• A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

  This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

• Managing Organic Impurities And Nitrosamines In APIs

  How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

• AI Has Arrived In Biotech CMC Amid Patchwork Governance

  AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.